FINAL THOUGHTS
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Tiffany P. Olson is the former president and CEO
of Roche Diagnostics Corp. (Indianapolis). She can be reached at olson_tiffany @msn.com. |
Pairing diagnostic tests with personalized treatments offers the promise of dramatic improvements in the efficacy of healthcare. But to realize that promise, the IVD industry and government need to work together in efficient and cooperative ways.
On the regulatory front, FDA’s Critical Path Initiative has the admirable goal of shortening the time to market for innovative medical products. Similarly, the agency’s draft guidance on in vitro diagnostic multivariate index assays (IVDMIA) is also a step in the right direction, although further clarification is needed.
Good patient care requires all clinical laboratory assays, not just genetic ones, to be validated and monitored to ensure the reliability of test results that are used to inform treatment. Accordingly, the amount of validation and monitoring should be commensurate with the degree of risk posed by the test and its application to patient care. Therefore, the intended use of a given test, not the analyte used, should be the focus of a review in order for proper regulatory goals to be achieved in the least burdensome manner.
In addition, FDA guidance is welcome on the evidentiary standards for validating the clinical utility and validity of different types of companion diagnostics. In this regard, it would be reasonable to have a different level of evidence required for validating a test to identify a rare genetic disorder, compared with a test that determines access to widely used medications.
The federal government’s role extends beyond the consistent and credible regulatory review of genetic assays. The government pays for diagnostic tests for its beneficiaries and as a result considers whether and how to cover and pay for such tests under its programs, which include Medicare. Without adequate coverage and payment for diagnostic tests, companion development may stall. The reason is simple: if the government and private insurers won’t pay for these tests, few providers will use them, and patients will not receive the benefits of the test or potentially the drug.
Lesson Learned
The first FDA-approved microarray, the AmpliChip by Roche Diagnostics, uses PCR technology to analyze a patient’s DNA. The test identifies possible variations in two important genes involved in metabolizing a large number of drugs. In theory, clinicians could use this information to adjust the drug dosage. In reality, however, there is still an incomplete understanding on how to use this genetic information to guide therapies. Therefore, even though FDA has cleared this test, utilization and reimbursement has been limited.
Personalized healthcare will reduce costs to the federal government in most cases. New test-and-therapy combinations may result in additional costs to the government in the short term. But where there are health benefits to patients that save the government money over the long term, Medicare should provide commensurate reimbursement to recognize the value of these products. In this way, since many private insurers follow the lead of the federal government, personalized diagnosis and treatment will enter the healthcare mainstream much more quickly, benefiting patients and reducing overall costs.
Intellectual property is another area filled with opportunities and challenges. The current legal framework will need some updating to take into account new realities and competing interests. For example, the government should stimulate investment with strong patent protection for innovations in companion diagnostic development. At the same time, it should address questions such as what happens when researchers discover the genetic reason why a particular drug helps only a percentage of the population. This is of particular concern when an investigator in industry or academia discovers an important gene variant and then attempts to develop highly restrictive licensing agreements that can potentially inhibit commercialization of a companion diagnostic. In such a situation, what are the implications for clearing and labeling drug-diagnostic companion products?
It’s possible to look at the past decade and celebrate the progress that has been made in companion development. Alternatively, progress has been lamentably slow compared with the potential. The right partnerships between government and the IVD industry will help remove many impediments to more rapid progress.
